A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects with Primary Non-metastatic Uveal Melanoma (NCT07015190)

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10).

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Mark Shackleton

Key inclusion data

Patient must have a diagnosis of primary non-metastatic uveal melanoma. Patient must be at high risk of metastasis defined by at least one of the following: Monosomy 3, Class 2 GEP or Stage 3 by AJCC. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patient must have adequate organ function at the time of the screening assessments. Patient must not have had any previous treatment for uveal melanoma.